High intensity interval training for patients with congenital heart defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine if a 12-week home-based high intensity interval training program can enhance exercise capacity in individuals aged 12 to 45 with congenital heart defects requiring a right ventricle to pulmonary artery conduit. Participants will be divided into an intervention group, which will undergo the exercise program, and a control group, which will receive the intervention after an initial control period. The study also seeks to identify factors that may predict the effectiveness of the exercise training on improving exercise capacity. The target conditions include truncus arteriosus, pulmonary atresia with a ventricular septal defect, and severe tetralogy of Fallot.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Congenital absence of an unobstructed connection between the right ventricle and pulmonary artery, requiring surgical implantation of a right ventricle to pulmonary artery conduit, including patients with:

   1. Truncus arteriosus
   2. Pulmonary atresia with ventricular septum defect
   3. Severe tetralogy of Fallot
   4. Other forms of pulmonary atresia with biventricular correction
2. Age 12 to 45 years.
3. Current follow-up in Academic Center for Congenital Heart Disease (ACAHA; Erasmus MC Rotterdam and Radboudumc Nijmegen).
4. Signed informed consent.

Exclusion Criteria:

1. Ventricular arrhythmias and/or channelopathy.
2. Implantable cardioverter defibrillator implantation due to inherited arrhythmia syndromes.
3. Left ventricular ejection fraction and/or right ventricular ejection fraction less than 30 percent.
4. Elite athletes (i.e. national team, Olympians, professional athletes, exercising equal to or more than 10 h/week, according to definition in 2020 European Society of Cardiology Guidelines for Sports Cardiology and Exercise in Patients with Cardiovascular Disease).
5. Cardiovascular lesions requiring intervention (according to international guidelines).
6. Cardiovascular intervention (surgery or catheterization) less than 6 months ago.
7. Cardiovascular medication changes less than 3 months ago.
8. Hospitalization for treatment of cardiovascular events less than 6 months ago.
9. Comorbidities or developmental delay impeding exercise training (e.g. neuromuscular disease, symptomatic myocardial ischemia, syndromic diagnoses such as trisomy 21).
10. Inability to provide informed consent.

Where it's running

• ErasmusMC
  Rotterdam, South Holland, Netherlands Recruiting
• Radboudumc
  Nijmegen, Gelderland, Netherlands Not yet recruiting

Study contacts

• Principal investigator: Beatrijs Bartelds, MD, PhD — Erasmus Medical Center
• Study coordinator: Anouk S Moerdijk, MD
• Email: a.moerdijk@erasmusmc.nl
• Phone: +31107036264

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Integrated prenatal and postnatal treatment for newborns with critical congenital heart disease

  This study is testing a new approach that combines care before and after birth for newborns with serious heart defects to see if it can improve their treatment and recovery.

  Recruiting Beijing Anzhen Hospital · Beijing · NCT06768008

• Effects of stenting on exercise capacity in patients with certain congenital heart defects

  This study is testing if a procedure to open blocked arteries can help people with certain heart defects, like d-TGA, ToF, and TA, exercise better.

  Recruiting UMC Utrecht · Amsterdam and 3 other locations · NCT05809310

• Evaluation of the MASA Valve for heart surgery in children

  This study is testing a new heart valve designed for children with certain heart defects to see if it is safe and helps improve their heart function.

  Recruiting at 5 sites PECA Labs · Peoria, Illinois and 4 other locations · NCT05452720

• Understanding heart issues in patients with congenital heart disease

  This study is trying to understand what causes symptoms like shortness of breath and palpitations in people with congenital heart disease, especially those with Tetralogy of Fallot, by using remote heart monitoring.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT05122962

• Monitoring oxygen levels in newborns with congenital heart defects

  This study is testing a new way to monitor oxygen levels in newborns with congenital heart defects to see how it can help doctors understand their heart and blood flow better.

  Recruiting McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT04106479

• Registry of patients with Tetralogy of Fallot using implantable defibrillators

  This study is creating a national registry to track adult patients in France with Tetralogy of Fallot who have implantable defibrillators, to better understand their health over time.

  Recruiting Paris Sudden Death Expertise Center · Paris · NCT03837574

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.